Quality Assurance Associate

Canadian Blood Services•Calgary, AB

6d•CA$86,400 - CA$101,700•Hybrid

About The Position

Canadian Blood Services is looking for a Regular full-time Quality Assurance Associate (QAA) to join our dynamic Quality Assurance team in Calgary, Alberta. In this role, you will be providing the organizational assurance that we meet safety, quality identity, purity, potency and accessibility requirements of our products and services. You will utilize your knowledge of Good Manufacturing Practices (GMP), this includes Blood Regulations as defined by Health Canada, CSA Blood and Blood Component Standards as well as relevant Cell, Tissues and Organs (CTO) regulations and standards as well as the theory and application of quality systems elements to the products and services provided by Canadian Blood Services.

Requirements

Completion of post-secondary education in a relevant discipline or equivalent experience.
Minimum 10 years' experience in a GMP manufacturing or pharmaceutical environment.
Minimum 5 years' experience in Quality Management and Continuous Improvement.
Technical skills in Quality Management Systems and Microsoft Office.

Nice To Haves

Minimum of 3 years' experience in the quality assurance function of a testing or diagnostics program or organization following Good Manufacturing Practices is preferred.
In-depth knowledge of Health Canada, CSA, and AABB standards.

Responsibilities

Maintaining controlled processes and applying Quality Management System principles across deviations, document management, retrieval/recall, validation, change control, audits, training, and corrective and preventive actions (CAPA).
Educating staff as to "why" GMP, as defined by Canadian Blood Services Quality Management System, are necessary and how these ideologies apply to the activities Canadian Blood Services undertakes.
Monitoring and enhancing product and service quality by analyzing data, conducting root cause investigations, and tracking improvements.
Leading and supporting audit activities for internal/external audits, accreditation assessments, and Health Canada inspections, including inspection readiness activities, ensuring timely completion of assigned corrective actions within agreed timelines.
Acting as a subject matter resource for Testing quality processes by providing coaching, informal training, and knowledge-sharing sessions on GMP, Good Documentation Practices, investigations, and risk-based decision making.
Identifying recurring quality issues, documentation gaps, and potential risks and sharing recommendations to support continuous improvement.
Performing all work in accordance with Canadian Blood Services Corporate Health and Safety Policies and Procedures, contributing to a safe and compliant work environment.